A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Squamous Cell Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 99 years
- Gender
- Both males and females
Description
Clinical objectives: To determine the efficacy of afatinib in patients with germline MET-N375S polymorphism. To determine the tolerability of afatinib in chemo-relapsed patients with germline MET-N375S polymorphism. Research objectives: To determine the prevalence of MET and TP53 mutations, as well ...
Clinical objectives: To determine the efficacy of afatinib in patients with germline MET-N375S polymorphism. To determine the tolerability of afatinib in chemo-relapsed patients with germline MET-N375S polymorphism. Research objectives: To determine the prevalence of MET and TP53 mutations, as well as HER2 and MET amplification, in various cancers, particularly head and neck cancers and lung cancers. To establish tumour cell lines, spheroids of xenografts for drug screening. Endpoints of study: To determine the response rate of SCC HN/lung with Met-N375S to afatinib. The secondary endpoints include progression-free survival and toxicity. Frequency of MET mutations and TP53 mutations in patients with cancer.
Tracking Information
- NCT #
- NCT04533321
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Boon Cher Goh National University Hospital, Singapore
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